Sandoz and Teva invalidate blockbuster apixaban patent and SPC

Following revocation proceedings brought by generic drug manufacturers Sandoz and Teva (case numbers: HP-2020-000042 and HP-2021-000003), the UK High Court has invalidated a patent owned by US pharmaceutical company Bristol Myers Squibb.

Sandoz and Teva bring claims

Initially, the companies brought the claims independently – Teva in January 2021, and Sandoz in November 2020. However, following a case management conference in March 2021, Sandoz and Teva moved to manage the case together. The action might help clear the way for the companies to launch their own generic version of one of the market’s most lucrative anticoagulant drugs. Recently, its market share has increased due to a heightened demand for anticoagulant drugs during the global coronavirus pandemic.

Bristol Myers Squibb owns EP 14 27 415 and a corresponding supplementary protection certificate, which is valid until 2026. These cover the compound apixaban, which the company markets under brand name Eliquis. By thinning the blood, the drug can help treat thromboembolic disorders such as blood clots, especially following hip or knee surgery.

According to external sources, apixaban alone generated around $7 billion in revenue for the company in 2021.

Applying for amendments

Sandoz and Teva brought a suit against Bristol Myers Squibb, claiming the invalidity of EP 415. According to the judgment, the parties claim that the patent does not make plausible that apixaban has useful factor Xa inhibitory activity, or would be useful in therapeutic situations. Nor, say the parties, could medical professionals use the patented drug for any other purpose. Since apixaban’s success depends on the use of an Xa inhibitor, the court examined the issue of plausibility to determine invalidity.

BMS also counterclaimed for infringement, which the claimants both admitted to, were the court to find the patent valid. The US company also applied to amend the EP 415 claims. Ultimately, however, the court invalidated the patent and corresponding SPC for lack of plausibility based on insufficiency. The court did acknowledge the amendments, but did not formally allow them as it would not “cure [the patent’s] invalidity”.

Protection across the pond

In separate but related US proceedings, Bristol Myers Squibb fared better. In 2020, the US District Court for the District of Delaware upheld US patent 6,967,208 and formulation patent US 9,326,945. Following appeals by generics companies Sigmapharm, Sunshine Lake Pharma, Hec Pharm and Uniche, the US Court of Appeals for the Federal Circuit upheld the first-instance decision. Now, no generic drugs can enter the US market until the patents expire in 2028.

The dispute is also not yet over in the UK, as Sandoz and Teva also brought claims against five formulation patents (case numbers: HP-2020-000048; HP-2021-000009).

Sandoz has since settled validity and infringement on four patents, EP 25 38 925, EP 30 17 811, EP 32 57 500 and EP 32 51 660, while the action is proceeding on claims one to seven of remaining patent EP 32 46 021. Teva’s actions were also pending in full for all five patents, although the EPO Technical Boards of Appeal has now revoked EP 925.

Chris Sharp

The UK High Court is due to consider the remaining four patents in a two-week trial commencing 28 April 2022.

Teva turns to Pinsents

It is no surprise that Teva turned to Pinsent Masons, its usual advisor in Europe, for the proceedings. The London office of the mixed firm is often seen acting for the generics company, which has previously also worked with Bristows. However, here the latter firm worked with Sandoz, which is a long-standing client for the firm.

As such, both Sandoz and Teva had separate legal representation at trial, but split the advocacy between them.

Pinsent Masons is also acting for Teva in proceedings brought in the Commercial Court in Ireland in relation to the compound patent/SPC and formulation patents. The trials are due to go ahead in late June 2022 with partner Ann Henry leading the case. Parallel proceedings are ongoing in Canada, as well as several other jurisdictions.

Gemma Barrett

Hogan Lovells and WilmerHale join up

UK patent attorney firm D Young & Co. is conducting EPO proceedings regarding the four remaining patents. The EPO Opposition Division has so far found two Bristol Myers Squibb patents invalid, while two remain in opposition.

WilmerHale is co-ordinating the European litigation for BMS while also representing the company in US proceedings. The team, led by Matthew Shade, appeared as counsel alongside Hogan Lovells in the UK. The latter regularly features in pharmaceutical cases in London, especially for innovator drug companies. Partner Daniel Brook led the case in this instance.

Daniel Brook

For Sandoz
8 New Square (London): Michael Tappin
Three New Square (London): Stuart Baran, Alice Hart
Bristows (London): Gemma Barrett (partner); associate: Adrian Chew, Jonathan Ross, Sophie Britton

For Teva
Three New Square (London) Justin Turner, Thomas Lunt
Pinsent Masons (London): Christopher Sharp (partner); associates: Kit Carter, Katie Lo
Pinsent Masons (Dublin): Ann Henry

For Bristol Myers Squibb
11 South Square (London): Iain Purvis, Anna Edwards-Stuart
Hogan Lovells (London): Daniel Brook (partner); associate: Emma Fulton (counsel)
WilmerHale (London): Matthew Shade (partner)

High Court of England and Wales, London
Richard Meade (presiding judge)

Invalidating four

Update 20.07.2022: The High Court has now invalidated four Bristol Myers Squibb patents, EP 32 46 021, EP 30 17 811, EP 32 51 660 and EP 3257 500, after judge Richard Meade found them invalid for obviousness over a piece of prior art dubbed Carreiro. Now Teva will be assessing for costs. However, BMS is yet to confirm if it will appeal the decision. At the same time, proceedings for the same patents are ongoing at the EPO.

JUVE Patent updated this article on 20.07.2022 to reflect the latest developments in the dispute between Sandoz, Teva and Bristol Myers Squibb.